Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies (PRESeNT)

Exposures to PRenatal and Postnatal Adverse Stressful Experiences: Multimodal Omics Signatures Underlying Stress Vulnerability and Resilience and as Novel Targets for Preventive Strategies.

The study aims at identifying:

1. specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.
2. specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk;
3. whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women;

In order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum.

Women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health.

Blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses.

Saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses.

Clinical and psychological data will be collected from women at all timepoints.

Study Overview

• Status: Recruiting
• Conditions: Perinatal Depression
• Intervention / Treatment: Procedure: Blood and saliva collection; Behavioral: Psychometric scales; Other: Smartphone app

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annamaria Cattaneo; Phone Number: +390303501361; Email: acattaneo@fatebenefratelli.eu

Study Locations

• Italy
  • Brescia, Italy, 25125
    • Active, not recruiting
    • IRCCS Centro San Giovanni di Dio Fatebenefratelli
  • Milano, Italy
    • Not yet recruiting
    • Ospedale San Raffaele
    • Contact: Francesco Benedetti
  • Milano, Italy
    • Not yet recruiting
    • Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco
    • Contact: Roberta Anniverno
  • Treviglio, Italy
    • Recruiting
    • ASST Bergamo Ovest
    • Contact: Marina Cattaneo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant women of a singleton pregnancy
• Age ≥ 18 years

Exclusion Criteria:

• Uterine anomalies and obstetric complications
• Comorbidity with severe or chronic diseases
• Substance abuse
• Language barrier

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control	Procedure: Blood and saliva collection; Blood and saliva samples from pregnant women; saliva samples from babies.; Behavioral: Psychometric scales; A battery of psychometric scales and questionnaires.; Other: Smartphone app; A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
Other: Depressed	Procedure: Blood and saliva collection; Blood and saliva samples from pregnant women; saliva samples from babies.; Behavioral: Psychometric scales; A battery of psychometric scales and questionnaires.; Other: Smartphone app; A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
Other: At high risk	Procedure: Blood and saliva collection; Blood and saliva samples from pregnant women; saliva samples from babies.; Behavioral: Psychometric scales; A battery of psychometric scales and questionnaires.; Other: Smartphone app; A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differentially expressed genes and biological pathways modulation	25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate and profile of DNA methylation	25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Cortisol levels	25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Immune-related factors levels	25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Smartphone app utility	From 25th of gestation to 12 months postpartum

Collaborators and Investigators

• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: PRESeNT; 1749118 (Other Grant/Funding Number: FRRB - Fondazione Regionale per la Ricerca Biomedica)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No